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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000030194
Receipt No. R000034491
Scientific Title Evaluation of improvement of higher brain function and safety by Collagen food containing tripeptide and cyclic dipeptide intake.
Date of disclosure of the study information 2017/12/01
Last modified on 2018/12/26

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Basic information
Public title Evaluation of improvement of higher brain function and safety by Collagen food containing tripeptide and cyclic dipeptide intake.
Acronym Evaluation of improvement of higher brain function and safety test
Scientific Title Evaluation of improvement of higher brain function and safety by Collagen food containing tripeptide and cyclic dipeptide intake.
Scientific Title:Acronym Evaluation of improvement of higher brain function and safety test
Region
Japan

Condition
Condition Healthy adults
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 In order to evaluate the improvement of higher brain function and safety by two foods with different contents intake, we conduct single blind group comparison study and evaluate height measurement, blood test, health diary, doctor's findings and evaluations, physical measurement, measurement of blood pressure and pulse, and RBANS test.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 2 month later , evaluation of cognitive functions by RBANS
Key secondary outcomes Blood test
Health diary
Doctor's findings and evaluations
Height measurement
Physical measurement
Measurement of blood pressure and pulse

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Single blind -investigator(s) and assessor(s) are blinded
Control Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Low dose:1 bag once a day :During meals once a day, take in miso soup, coffee, tea etc. together with hot drinks that are usually drunk and ingest them together. Or take a meal with water or lukewarm water.
Interventions/Control_2 High dose:6 tablets once a day :After meals once a day, ingest with water or lukewarm water.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
40 years-old <=
Age-upper limit
69 years-old >=
Gender Male and Female
Key inclusion criteria 1 Japanese male and female at the age of 40 to 69 at first observation including screening.
2 A person who feels more forgetful than early life.
Key exclusion criteria 1 A person who possibly shows food allergy symptom.
2 A person who had been treated, hospitalized or operated for stroke, subarachnoid hemorrhage, cerebral infarction, cerebral haemorrhage, brain contusion or head trauma.
3 A person who is alcohol or nicotine addict, or whose dietary habit is extremely irregular.
4 A person with medical history or current illness of hepatic disorder.
5 A person with severe anemia.
6 A person with medical history of epileptic stroke, diabetes, thyroid dysfunction or severe renal dysfunction(hemodialysis, uremia, anuria), or attending the hospital regularly for these disorder.
7 A person who has taken a neuropsychological test at hospital.
8 A person who joins other human clinical study.
9 A person who is routinely taking medicines (e.g. antipsychotic, antianxiety agent, antidepressant, antiparkinson agent, antimanic agent, anticonvulsant, anticoagulant agent) which possibly affects the test results.
10 A person who is routinely taking health foods (supplements effective for antioxidative, blood flow-ameliorating and so on) which possibly affects the test results.
11 A person who is judged inappropriate to join the study by doctor in charge. (Subject who is judged inappropriate during this test is excluded from targets of analysis. In addition, a criterion not in screening criteria is not included in exclusion criteria for screening.)
12 A person who have taken an RBANS test in 3 month before main test schedule.
Target sample size 16

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takashi Koikeda
Organization Shiba Palace Clinic
Division name Chair
Zip code
Address 6F DaiwaA Hamamatucho Bld., 1-9-10 Hamamatsucho, Minato-ku, Tokyo, 105-0013, Japan
TEL 03-5408-1590
Email jimukyoku@mail.souken-r.com

Public contact
Name of contact person
1st name
Middle name
Last name Ko MASUDA
Organization SOUKEN Co., Ltd
Division name Management Division
Zip code
Address 3F DaiwaA Hamamatucho Bld., 1-9-10 Hamamatsucho, Minato-ku, Tokyo, 105-0013, Japan
TEL 03-5408-1555
Homepage URL
Email k_masuda@mail.souken-r.com

Sponsor
Institute Shiba Palace Clinic
Institute
Department

Funding Source
Organization JELLICE Co., Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2017 Year 12 Month 01 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2017 Year 08 Month 24 Day
Date of IRB
Anticipated trial start date
2017 Year 10 Month 17 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 11 Month 30 Day
Last modified on
2018 Year 12 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034491

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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